Detachable guide needle

ABSTRACT

Methods of forming detachable guide needle devices which are utilized in conjunction with flexible catheters in withdrawing or introducing fluids relative to a body, said method including the stamping of a guide needle blank, the impression of break-apart hinge means therein, and the folding thereof in a manner which will provide separation of the guide needle into detached sections after use thereof for complete removal from an associated flexible catheter.

United States Patent [72] Inventor Carl W. Lange [56] References Cit d 2] A l N gzegllgiltnes, Ill. UNITED STATES PATENTS 1 .P 3,291,336 12/1966 Fraze...- 220/54 3 359 97s l2/l967 s 1:11 128/2l4 4 I45] Pmcmcd octlzwn m .1 73 Assignee 111111618 Tool Works Inc. FOREIGN PATENTS Chicago, Ill. 109,789 l/l968 Denmark l28/2l4.4

Primary Examiner-Dalton L. Truluck Attorneys-Robert W. Beart, Michael Kovac, Barry L. Clark and Jack R. Halvorsen [541 g g P NEEDLE ABSTRACT: Methods of forming detachable guide needle 6 rawmg devices which are utilized in conjunction with flexible [52] U.S.C| 113/116, Catheters in withdrawing or introducing fluids relative to a 128l2l4.4 body, said method including the stamping of a guide needle [51] Int. Cl 1. B2ld 53/06, blank, the impression of break-apart hinge means therein, and A61m 05/00 the folding thereof in a manner which will provide separation [50] Field of Search 1 13/1 16 of the guide needle into detached sections after use thereof for DD; 128/2 14.4 complete removal from an associated flexible catheter.

IO I4 14 y I DETACIIABLE GUIDE NEEDLE The present invention is directed to methods of forming detachable guide needle constructions which are used with flexible catheters in various types of surgical procedures such as intravenous feeding, the taking of blood samples, and other similar techniques where fluid is either withdrawn or introduced relative to a body. At present, guide needles have been retained on the flexible catheter after the venipuncture has been made and the catheter tube has been inserted in the selected vein; however, this not only creates potential hazards to the patient, but also, as is more likely, much discomfort is experienced by the patient. In an attempt to alleviate patient injury and/or discomfort, several makeshift approaches are currently utilized, and these have involved the taping of the needle to the arm or other member of the patient, shielding the needle in one fashion or another, or the contriving of variousexpedients by the nurse or doctor involved. It has been found that the above approaches not only have failed to solve the problems inherent in the use of guide needles, but also give rise to nonuniform surgical procedures for nurses and other attendants who aid the attending physician.

Detachable guide needles which are manufactured by the method of the present invention are capable of being completely removed from the flexible catheter tube after venipuncture has been made and the flexible catheter inserted into the selected vein. For specific description of the types of guide needle devices which can be manufactured by the method of the present invention, reference is made to copending U.S. Pat. applications Ser. Nos. 826,969 and 826,970 filed May 22, I969, which in turn are improvements over the removable -guide needle constructions disclosed and claimed in US. Pat. No. 3,359,978.

One object of the present invention is to provide a method for manufacturing detachable guide needle constructions for use with a flexible catheter tube wherein the guide needle may be separated into detached sections for complete removal from the flexible catheter.

Another object of the present invention is the provision of a precision manufacturing technique for detachable guide needles which requires a minimum number of procedural steps or operations.

A further object of the above described method includes its adaption to low cost, high-speed, repetitive, mass-manufacturing techniques.

These and other objects and advantages of the present invention' are attained by the provision of a method of forming a detachable, one-piece, hollow guide needle which is capable of being used with a flexible catheter in withdrawing or introducing fluids relative to a body, the method comprising the steps of stamping from sheet stock material an elongated guide needle blank having handle means on opposite sides thereof at one end, folding said elongated guide needle blank throughout its longitudinal length into a U-shaped configuration, impressing in central surface portions of said U-shaped blank configuration break-apart hinge" means throughout the entire longitudinal extent thereof by forming an intermittently scored longitudinal portion with integral, frangible connecting webs between the scored portions, and thereafter folding said U-shaped guide needle blank until opposite sides of said blank away from said handle means are juxtaposed relative to one another to provide a line of separation therebetween, said handle means on opposite sides of said blank being folded to a position of initial juxtaposition relative to one another as the remaining portions of the guide needle are folded in the aforementioned manner.

Reference is now made to the drawings wherein:

FIG. IA is an enlarged fragmentary top plan view of a guide needle blank which is stamped from sheet stock material;

FIG. 1B is an end elevational view of the guide needle blank shown in FIG. IA as viewed along lines IB-'-IB thereof;

FIG. 2A is a fragmentary top plan view of the guide needle blank with the opposite edge portions thereof deformed into generally opposed, upstanding leg portions during the second stage or step of the guide needle manufacture;

FIG. 2B is an end elevational view of the guide needle blank shown in FIG. 2A as viewed along lines 2B-2B thereof;

FIG. 3A is a fragmentary top plan view of the guide needle blank during the next phase or step of its fabrication during which it is formed into a generally U-shaped configuration;

FIG. 4 is a top plan view of the guide needle blank which illustrates the step of impressing an intermittently scored, longitudinal portion in the guide needle blank generally in the bight portion thereof intermediate the upstanding legs of its U- shaped configuration;

FIG. 5 is an enlarged fragmentary side elevational, sectional view of the intermittently scored, longitudinal portion of the guide needle blank;

FIG. 6 is a top plan view of the guide needle blank which depicts the phase or step during the guide needle manufacture in which frangible, connecting webs between the longitudinal scored portions are formed;

FIG. 7 is an enlarged fragmentary side elevational, sectional view illustrating the longitudinally scored and integral, frangible connecting web portions of the break-apart hinge means of the guide needle;

FIG. 8A is a top plan view of the guide needle blank which illustrates the forming of the elongated portion of the guide needle into a tubular or cylindrical portion;

FIG. 8B is a view of the guide needle shown in FIG. 8A as viewed along lines 8B-8B thereof;

FIG. 9 is a fragmentary top plan view of the guide needle illustrating the provision of a sharpened, pointed end configuration which is preferably formed as the last stage of the fabrication of the guide needle;

FIG. 10 is an enlarged perspective view of the completed detachable guide needle which is manufactured in accordance with the teachings of the present invention;

FIG. 11 is also an enlarged perspective view of the detachable guide needle shown in FIG. 10, but illustrating the manner in which the needle is separated for lateral removal and detachment from a flexible catheter;

FIG. 12 is a top plan view of the guide needle blank which is scaled approximately to the actual size of the blank initially formed in the guide needle manufacture according to the present invention;

FIG. 13 is an-enlarged side elevational view of one of the detached sections of the detachable guide needle as illustrated in FIG. 11;

FIG. 14 is a substantially enlarged fragmentary, sectional view of the break-apart hinge means of the detachable needle as viewed along lines l4-I4 of FIG. I3; and

FIG. 15 is a further substantially enlarged fragmentary, sectional view illustrating a portion of the break-apart hinge means of the detachable guide needle in the vicinity of the handle means thereof.

The method of fabricating detachable guide needle constructions according to the present invention will be facilitated by referring first to the general type of guide needle constructions which are susceptible of manufacture by the procedure of the present invention.

Referring first to FIGS. 10-15, it will seen that the detachable guide needle 10 is of the type which is designed for use with a flexible catheter l2 depicted in FIG. I I in withdrawing or introducing fluids relative to a body. The detachable guide needle 10 serves the functions of making the venipuncture as well as carrying the flexible catheter 12 which is then inserted into the opening in the vein. Thereafter, the needle 10 is removed from the body with the flexible catheter 12 left intact, and the needle 10 may then be completely detached or removed from the flexible catheter 12 so as to avoid the inherent difficulties that are present in keeping the needle mounted to or otherwise associated relative to a flexible catheter l2.

The detachable guide needle 10 shown in FIG. 10 includes a hollow body section 14 with a sharpened configuration 15 at one end. At the other end of the hollow body section 14, there is provided integral handle means I6 which includes a pair of juxtaposed wing elements 18, 20. Each of the wing elements 18, 20 are provided with reinforcing struts 22, 24 which are preferably grooves or depressions arranged in noninterfitting relationship on the wing elements 18, 20 so that the reinforcing struts 22, 241 do not interfit one within the other. It will be noted that the integral wing sections 18, 20 include longitudinally offset portions from one another so as to permit rapid and simple manipulative removal of the guide needle from the flexible catheter 12 as will be explained below. The handle means 16 of the detachable guide needle 10 thus not only provides controlled insertion of the needle into the desired vein of the body, but also facilitates removal of the guide needle 10 from the flexible catheter 12, all as more fully disclosed and claimed in U.S. Pat. application Ser. No. 814,977, filed Apr. 10, I969.

The hollow body section 14 of the guide needle 10 includes a longitudinal line of separation 26 along the upper surface thereof and extending throughout the entire length of the hollow body section 14 including the integral wing elements 18, 20. The detachable guide needle 10 is further provided with break-apart hinge means 28 which extends along the lower surface of the needle in generally opposed relationship and extending longitudinally throughout the entire length of the needle in the same manner as the line of separation 26. The break-apart hinge means 28 serves the important function of separating the guide needle 10 into two detached sections when the needle 10 is opened up a predetermined amount by the wing sections 18, 20 of the handle means along the line of separation 26. This is illustrated in FIG. 11 of the drawings wherein there is shown the two detached sections which have been formed as the result of opening up the needle by the handle means 16 along the line of separation 26 after the needle has served its purpose in permitting venipuncture and in the positionment of the flexible catheter 12 within the opening of the punctured vein.

The break-apart hinge means 28 includes, as best seen in FIGS. 12-15, an intermittently scored longitudinal portion, each score being identified 30 in FIG. 14 of the drawing. The scores 30 preferably extend substantially throughout the entire thickness of the guide needle so as to offer no resistance in separation of the needle into two detached sections therealong. Between each of the intermittent scores 30, there is provided integral, frangible connecting webs 32 which serve to hold the detachable sections of the needle together until separation or removal from a flexible catheter 12 is desired. This is achieved by fracturing the connecting webs 32 as the needle is opened along the line of separation 26 by the handle means 16.

In order to achieve uniform opening of the needle 10 along the line of separation 26, the integral connecting web 34 at the rear or distal end of the needle adjacent the handle means 16 has a higher fracture level than the integral connecting webs 32, and thus is capable of maintaining the integral connecting webs 32 as hinges until sufficient force is applied to weaken and fracture the frangible, integral connecting webs 32. Continued application of the force will also result in the fracture of the connecting web 34 so as to provide the detached sections of the needle illustrated in FIG. 11 facilitating complete removal from the flexible catheter 12. It has been found that the integral connecting web 34 assures substantial simultaneous fracture of the connecting webs 32 and thereby provides positive separation of the detachable sections of the guide needle 10.

Needles of the above described type are more fully disclosed and claimed in the aforementioned U.S. Pat. applications Ser. Nos. 826,969 and 826,970, filed May 22, 1969.

The method for manufacturing needles in accordance with the present invention is accomplished as follows: Referring now to FIGS. 1-9 of the drawings, the various stages or steps of the guide needles fabrication is depicted. The needle 10 is first formed, as shown in FIGS. lA-lB, by being stamped or blanked from sheet stock material into the one-piece, elongated shape which is shown. Preferably, the sheet stock is stainless steel having a thickness, for example, of 0.006 inches such that it has the characteristics of a rigid, relatively thin, noncorrosive and sanitary needle for use in puncturing the tissues, muscles and veins of the human body. It will be understood that other types of equivalent materials may be utilized in practicing the method of the present invention.

During the first step or phase of the manufacturing operation, the wing sections 18, 20 of the handle means is preferably provided with strengthening or reinforcing means such as, for example, the grooves or depressions 22, 24 which provide reinforcing struts for the handle means. It will be appreciated that other shapes, impressions or configurations may be provided in the handle means to accomplish the sought after reinforcing or rigidifying purpose in connection with the handle means.

During the next phase or step of the guide needles fabrication, it is necessary to fonn the elongated guide needle blank into a U-shaped configuration. While this preferably comprises a two-state procedure, the present invention contemplates a one-step formation of the guide needle blank into a U- shaped configuration. As illustrated in FIGS. 2A-2B, the opposite edge portions 14a, 14b of the guide needle blank are formed into generally opposed, but inclined, upstanding leg portions with the remaining portion 14c serving as the bight or connecting portion therebetween. It will be appreciated that the guide needle blank, including the central or medial portion between the handle means 18, 20 is formed in the manner just described.

Once the guide needle blank has been preliminary formed as described in connection with FIGS. 2A-2B, it facilitates the formation of the U-shaped guide needle configuration illustrated in FIGS. 3A-3B. In these latter two figures, the guide needle is formed to what is clearly depicted in the end elevational view of FIG. 38, as a general U-shaped configuration throughout the entire longitudinal length thereof, including the central or medial portion connecting the handle means 18, 20.

During the next phase of the manufacturing operation, the guide needle blank is formed with break-apart hinge means 28 previously described throughout the entire longitudinal extent of the guide needle. While this is also preferably a two-stage to step procedure, it is conceivable that a single-step operation is possible.

As shown in FIGS. 4-5 of the drawings, the first step in the formation of the break-apart hinge means comprises the formation of an intermittently scored longitudinal portion, comprising longitudinally spaced scores 30, which are formed in the bight or connecting portion of the U-shaped needle. It will be noted, as clearly depicted in FIG. 5 of the drawings, that the scores 30 are impressed in the sheet stock material substantially throughout the thickness thereof for the purpose of enhancing the separation of the guide needle into two detached sections as previously described.

The break-apart hinge means 28 is completed by scoring or localized hardening of the connecting portions between the scores 30 to form integral, frangible connecting webs 32 as il lustrated in FIGS. 67 of the drawings. It will be appreciated that the frangible, connecting webs 32 are provided with a slightly higher fracture level due to a smaller displacement of the material by the application of different levels of pressure through a complementary configured tool means and backup tool or anvil.

During the formation of the break-apart hinge means 28, an integral connecting web 34, as illustrated in FIG. 15 of the drawings, is preferably retained at substantially the thickness of the sheet stock material or at a higher fracture level than that which is provided for the scores 30 and the frangible connecting webs 32.

After the break-apart hinge means is thus formed in the guide needle, the final forming operation is illustrated in FIGS. 8A-8B. In these two latter figures, the U-shaped configuration is then configured as a cylindrical or tubular hollow body section 14. This is accomplished by folding or forming the legs 14a, 14b until the edge portions thereof are juxtaposed relative to one another to provide the line of separation 26 therebetween. After the needle assumes its ultimate configuration, a sharpened or pointed configuration 15 may be provided at the proximate or forward end thereof for puncturing the skin, tissues, etc.

Once formed in accordance with the above method, the needle 10 is then ready for use with the flexible catheter 12 in withdrawing or introducing fluids relative to a body. The method of the present invention provides an improved procedural technique enabling precision manufacture of guide needles with a minimum number of steps and a high-speed, repetitive, mas-manufacturing assembly line.

I claim:

1. The method of forming a detachable, one-piece, hollow guide needle which is capable of being used with a flexible catheter in withdrawing or introducing fluids relative to a body, comprising the steps of stamping from sheet stock material an elongated guide needle blank having handle means on opposite sides thereof at one end, folding said elongated guide needle blank throughout its longitudinal length into a U-shaped configuration, impressing in central surface portions of said U-shaped blank configuration break-apart hinge means throughout the entire longitudinal extent thereof by forming an intermittently scored longitudinal portion with integral, frangible connecting webs between the scored portions, said integral frangible connecting webs being formed by impressing depressions of lesser depth than said scored per tions in said needle blank, and thereafter folding said U- shaped guide needle blank until opposite sides of said blank away from said handle means are juxtaposed relative to one another to provide a line of separation therebetween, said handle means on opposite sides of said blank being folded to a position of initial juxtaposition relative to one another as the remaining portions of the guide needle are folded in the aforementioned manner.

2. The method as set forth in claim 1 wherein said blank is folded into said U-shaped configuration by first deforming opposite edge portions of said blank into generally opposed upstanding leg portions and then shaping the thus formed blank into said U-shaped configuration.

3. The method as set forth in claim 1 wherein the intennittently scored longitudinal portion and the integral, frangible connecting webs are impressed in said guide needle blank in consecutive sequence.

4. The method as set forth in claim 1 wherein the intermittently scored longitudinal portion and the integral, frangible 

1. The method of forming a detachable, one-piece, hollow guide needle which is capable of being used with a flexible catheter in withdrawing or introducing fluids relative to a body, comprising the steps of stamping from sheet stock material an elongated guide needle blank having handle means on opposite sides thereof at one end, folding said elongated guide needle blank throughout its longitudinal length into a U-shaped configuration, impressing in central surface portions of said U-shaped blank configuration break-apart hinge means throughout the entire longitudinal extent thereof by forming an intermittently scored longitudinal portion with integral, frangible connecting webs between the scored portions, said integral frangible connecting webs being formed by impressing depressions of lesser depth than said scored portions in said needle blank, and thereafter folding said U-shaped guide needle blank until opposite sides of said blank away from said handle means are juxtaposed relative to one another to provide a line of separation therebetween, said handle means on opposite sides of said blank being folded to a position of initial juxtaposition relative to one another as the remaining portions of the guide needle are folded in the aforementioned manner.
 2. The method as set forth in claim 1 wherein said blank is folded into said U-shaped configuration by first deforming opposite edge portions of said blank into generally opposed upstanding leg portions and then shaping the thus formed blank into said U-shaped configuration.
 3. The method as set forth in claim 1 wherein the intermittently scored longitudinal portion and the integral, frangible connecting webs are impressed in said guide needle blank in consecutive sequence.
 4. The method as set forth in claim 1 wherein the intermittently scored longitudinal portion and the integral, frangible connecting webs are simultaneously impressed in said guide needle blank.
 5. The method as set forth in claim 1 including the step of providing a sharpened portion on the elongated guide needle at the end thereof opposite said handle means.
 6. The method as set forth in claim 1 wherein the sharpened portion is formed after the guide needle assumes its ultimate configuration. 